Guidance on information and submission requirements for biosimilar biologic drugs: Information requirements for new drug submissions
Part C, Division 8 of the Food and Drug Regulations (FDR) sets out the requirements for the sale of new drugs in Canada, which include biosimilars, and prohibits the sale of new drugs unless the manufacturer has filed a submission that is satisfactory to the Minister. Section C.08.002 of the FDR outlines the requirements for a new drug submission (NDS).
Organization of data
Electronic documents should be provided in electronic common technical document (eCTD) format.
The Filing submissions electronically includes links to documents that provide detailed information on these formats and other information relating to filing submissions electronically.
The assessment of similarity should be organized as a distinct collection of data in section 3.2 R.5 Assessment of Similarity.
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